AbbVie has filed a New Drug Application with the US Food and Drug Administration (FDA) for tavapadon, a selective dopamine D1/D5 receptor partial agonist that has been investigated as a once-daily oral treatment for Parkinson's disease. The submission draws on findings from the TEMPO clinical development programme, which assessed the tolerability, efficacy, and safety of tavapadon in various populations with Parkinson’s disease. This programme included two Phase III trials (TEMPO-1 and TEMPO-II focused on early Parkinson’s disease and one Phase III study investigating tavapadon as an adjunctive treatment to levodopa in patients facing motor fluctuations. AbbVie research and development executive vice president and chief scientific officer Roopal Thakkar said: “For many people living with Parkinson’s disease, today’s oral standard of care isn’t effective enough to manage symptoms. “We recognise the physical and mental impact that Parkinson’s disease can cause and are committed to providing next-generation treatment options that will help individuals regain motor control and independence at all stages of this challenging disease.”